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niacin laropiprant simvastatin

Phase 3

Primary Hypercholesterolemia | Small molecule | Cardiovascular |Merck & Company, Inc.|Last Updated: Apr 7, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment1,400

FDA Designations

No designations recorded

Clinical trial landscape

niacin laropiprant simvastatin · 1 trial · 2 indications

Phase 3 1
NCT00269217Lipid Efficacy Study (0524B-022)(COMPLETED)Primary Hypercholesterolemia
COMPLETED1,400 Analytics
PHASE3COMPLETED
Lipid Efficacy Study (0524B-022)(COMPLETED)
Primary Hypercholesterolemia
NCT002692171,400
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Study Endpoints

Primary Endpoints

Coadministered MK0524B will be more efficacious in reducing LDL-C concentrations compared to MK0524A.

Secondary Endpoints

Coadministered MK0524B will have a greater effect on HDL-C, TG, LDL-C, LDL-C:HDL-C, non-HDL-C, Apo B, and Apo A-I than simvastatin.
Coadministered MK0524B will have a greater effect on HDL-C, TG, LDL-C:HDL-C, non-HDL-C, Apo B, and Apo A-I than MK0524A.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
niacin (+) laropiprant (+) simvastatinDRUGDuration of Treatment 12 Weeks
Comparator: niacin (+) laropiprantDRUGDuration of Treatment 12 Weeks
Comparator: simvastatinDRUGDuration of Treatment 12 Weeks
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Eligibility Criteria

Age Range18 Years to 85 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patients 18 to 85 years of age with primary hypercholesterolemia or mixed hyperlipidemia * LDL-C between 130 and 190 mg/L (Category I) and 130 and 160 mg/L (Category II) and triglycerides \</= 350 mg/dL. Exclusion Criteria: * A condition which, in the opinion of the investig...

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Frequently asked questions about niacin laropiprant simvastatin

What is niacin laropiprant simvastatin used for?

Niacin laropiprant simvastatin is a combination drug being developed for primary hypercholesterolemia, a condition of elevated cholesterol levels. It is a small molecule therapy in the cardiovascular therapeutic area. The drug is currently in Phase 3 clinical development and is not yet approved.

Who makes niacin laropiprant simvastatin?

Niacin laropiprant simvastatin is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 3 clinical trials for primary hypercholesterolemia.

What phase is niacin laropiprant simvastatin in?

Niacin laropiprant simvastatin is in Phase 3 clinical development. It is an investigational drug being studied for primary hypercholesterolemia and has not been approved by regulatory authorities. One Phase 3 trial has been completed, with no active trials currently ongoing.

What clinical trials is niacin laropiprant simvastatin in?

Niacin laropiprant simvastatin has one completed Phase 3 clinical trial registered under NCT00269217, titled 'Lipid Efficacy Study (0524B-022)(COMPLETED)'. This randomized, double-blind trial enrolled 1400 participants with primary hypercholesterolemia or mixed hyperlipidemia, aged 18 years and older.

Is niacin laropiprant simvastatin FDA approved?

Niacin laropiprant simvastatin is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for primary hypercholesterolemia. The drug has completed one Phase 3 trial, but approval status has not been established.